EU Panel Reviewing Safety of Methadone Containing Povidone

Megan Brooks

April 11, 2014

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of oral methadone medicines that contain povidone.

Methadone-containing medicines are used in rehabilitation programs in patients dependent on heroin and other opioids to prevent or reduce withdrawal symptoms to decrease the chance of relapse.

According to the EMA, the review was triggered by the Norwegian Medicines Agency after reports of kidney failure in former or current drug abusers, which may be linked to the misuse of methadone oral solutions containing certain types of povidone.

"Various forms of povidone are available, which vary in the size of the molecule. The forms that have been linked to the reported kidney problems have a large molecular size," the EMA said.

"These medicines are intended for oral use only; however, some patients may abuse oral methadone preparations and inject them into a vein. If a medicine containing these forms of povidone is abused in this way, there are concerns that povidone can accumulate inside the cells of vital organs. This is not considered to occur when oral methadone medicines are used as recommended," the EMA said.

Because of these concerns, Norway suspended Martindale Pharma's methadone 2 mg/mL oral solution, the only methadone-containing oral solution that contains povidone present on the national market, and asked the EMA to review whether there are implications for the use of all oral methadone medicines containing povidone in other European Union member states.

In the European Union, oral methadone medicines containing povidone are currently available in Bulgaria, Denmark, Finland, Hungary, Iceland, Luxembourg, Malta, Norway, Romania, Slovakia, Spain, Sweden, and the United Kingdom.

The EMA's PRAC will review this safety concern and its effect on the balance of benefit to risk for oral methadone medicines that contain povidone. The PRAC has invited healthcare professionals, patients' organizations, and the general public to submit data relevant to the following questions by May 2, 2014:

  • Question 1: Please provide your views on the benefit–risk balance of methadone medicinal products for oral use containing povidone in the treatment of opioid-dependent patients.

  • Question 2: Please provide any relevant information you may have on the misuse by injection of methadone medicinal products for oral use containing povidone.

  • Question 3: Are you aware of alternative risk minimization measures (instead of or in addition to povidone) that might result in a more favorable benefit/risk profile of methadone for oral administration?

After their review, the PRAC will issue an opinion on whether marketing authorizations should be maintained, varied, suspended, or withdrawn across the European Union. The recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.


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